Services for Pharma and Life-Science

 

 

FDA Audits We have gained our experience in 75 FDA inspections.
Take advantage of our knowledge.

 

We offer "mock-audits" by a former FDA Inspector, as well as, assistance in the preparation, execution and evaluation of FDA inspections for the following kinds of FDA inspections:

We offer in-depth assistance in the preparation phase to identify and address quality issues and train and prepare the staff. During inspection we operate as a moderator, note-taker and provide professional interpretors from our team. We arrange the pick-up service of the inspector from the hotel, the establishment of inspection and back-office zones, we propose reliable communication design and train the involved people, to provide the necessary confidence in dealing with this unusual situation. In addition, we explore the complex psychology of the entire inspection phase of the announcement until the conclusion of the possible reworking in order to apply specific measures optimally.

But no FDA inspection is like another, because FDA inspections are affected by personal characteristics of the inspectors and auditees. For this reason, it is necessary to work-out an individual approach with you as a customer to ensure that the inspection will be successful. We define as a success if no FDA Form 483 observations is achieved. This result was achieved in many of our 75 FDA inspections.

The U.S. Food and Drug Administration "Food and Drug Administration" has doubled its annual budget of about $ 2 billion in 2008 to approximately $ 4 billion in 2011 and it grew the number of foreign inspections in the pharmaceutical sector nearly doubled to, medical by a factor of 1.9 and for foods and food additives to the fifth factor.

Thus in Germany in 2010 already 132 FDA inspections were conducted - with an upward trend (see Support for FDA inspections). With its on-site investigations the FDA verifies if an institution operates in accordance with U.S. laws. The common practice is that all participating companies and contractors concerned in submitting a product for the U.S. market are reviewed for compliance with these laws. In order to obtain approval to market, all companies involved in the submission, i.e. Sponsors, contractors as well as contract manufacturers and contract laboratories have to pass the inspection successfully.

 


 

FDA Warning Letters

Searchable >> Warning Letters list available on the FDA web pages.